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Safety and Efficacy of QD Versus BID Silodosin With Lower Urinary Tract Symptoms Suggestive of BPH

Primary Purpose

Benign Prostatic Hypertrophy

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Silodosin
Silodosin
Sponsored by
JW Pharmaceutical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Benign Prostatic Hypertrophy focused on measuring BPH, silodosin

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

Patients who have been diagnosed with BPH through digital rectal exam or ultrasonographic findings and meet the following criteria.

  • Outpatients aged 50 or over
  • Patients with a total I-PSS score of 8 or higher and a QoL score of 3 or higher
  • Patients with a prostate volume measured by transabdominal ultrasonography, or TRUS of 20 ml or greater
  • Patients with a maximum urinary flow rate (Qmax_) of 15ml/sec or below (whose a void urinary volume of 120ml or greater)

Exclusion Criteria:

  • Patients with a residual urinary volume of 200ml or greater
  • Patients with a history of prostatectomy
  • Patients with a history of intrapelvic radiation therapy
  • Patients with a history of prostatic hyperthermia
  • Patients with prostate cancer or suspected prostate cancer
  • Patients with complications considered likely to affect urinary passing such as neurogenic bladder, bladder calculus and active urinary tract infection. UTI
  • Patients conducting self-catheterization
  • Patients with renal impairment (serum creatinine of 3.0 mg/dl or greater)
  • Patients with severe heptic disorders (hepatic insufficiency, cirrhosis, jaundice, hepatoma) or with a total bilirubin of 3.0mg/dL or greater or AST/ALT 2.5 times higher than normal level
  • Patients with history of severe arrhythmia, cardiac failure, cardiac infarction, unstable angina, cerebral infarction within 6 months
  • Patients with a history of an allergy to α-blockers
  • Patients with orthostatic hypotension at around screening visit
  • Patients with an experience of other investigational product treatments within 4 weeks form screening visit.
  • Patients with a PSA of 10 or over, Patients with tumor identified by a prostate biopsy with a PSA of 4 or over (For patients taking 5α-reductase inhibitors for more than 3 months are presumed to have double than their actual PSA levels.)
  • Patients who have taken unstable doses of antidepressants within the 3 months or who are expected to take unstable doses during the study
  • Patients who have taken alpha blockers within the 2 weeks from the start of the therapy
  • Patients who have taken unstable doses of 5α-reductase inhibitors within the 3 months from the start of the therapy or who are expected to take unstable doses during the study.
  • Patients disqualified by the investigator.

Sites / Locations

  • The Catholic Univ., Bucheon ST.Mary's Hospital
  • Busan National Univ. Hospital
  • Konkuk Univ, Chungju Hospital
  • Choongnam National Univ. Hospital
  • Eulji Univ. Hospital
  • Chonnam Univ. Hospital
  • Inha Univ. Hosipital
  • Asan Medical Center
  • Chungang Univ. Hospital
  • Korea Univ. Hospital
  • Samsung Medical Center
  • Seoul National University Hospital
  • Severance Hospital
  • The Catholic Univ., Seoul ST.Mary's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Silodosin 8 mg

Silodosin 4 mg

Arm Description

Outcomes

Primary Outcome Measures

I-PSS
Change in I-PSS total score from baseline

Secondary Outcome Measures

I-PSS, Qmax, QoL, ICS Male Questionnaire, goal achievement, Treatment satisfaction question
The rate of patients who experience a decrease in I-PSS total score of 25% or higher The rate of patients who experience an improvement of at least 4 in I-PSS total score I-PSS Change in Qmax from baseline The rate of patients who experience an improvement of 30% or over in Qmax Change in the I-PSS voiding and storage scores from baseline Change in QoL score from baseline Change in ICS Male Questionnaire from baseline Patient's goal achievement score Treatment Satisfaction Question

Full Information

First Posted
October 28, 2010
Last Updated
March 28, 2012
Sponsor
JW Pharmaceutical
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1. Study Identification

Unique Protocol Identification Number
NCT01260129
Brief Title
Safety and Efficacy of QD Versus BID Silodosin With Lower Urinary Tract Symptoms Suggestive of BPH
Official Title
Safety and Efficacy of 8mg Once-daily Versus 4mg Twice-daily Silodosin With Lower Urinary Tract Symptoms Suggestive of BPH ; 12-week, Double-blind, Randomized, Comparison, Multi-center Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
JW Pharmaceutical

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Korea has newly adopted 8mg Silodosin once daily. Against these backdrops, this clinical study is designed to demonstrate that the newly adopted dose is not inferior to the existing dose in its efficacy and safety.
Detailed Description
Silodosin is a highly selective α1A-adrenoceptor antagonist for the treatment of the signs and symptoms of BPH. 4mg Silodosin twice daily has been approved in Asia including Japan and Korea. In US, 8mg Silodosin once daily with the FDA approval is already available. Korea has newly adopted 8mg Silodosin once daily. Against these backdrops, this clinical study is designed to demonstrate that the newly adopted dose is not inferior to the existing dose in its efficacy and safety. The study used double-blind, random assignment in Korean men with signs and symptoms of BPH for 12 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Prostatic Hypertrophy
Keywords
BPH, silodosin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
424 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Silodosin 8 mg
Arm Type
Experimental
Arm Title
Silodosin 4 mg
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Silodosin
Intervention Description
Silodosin 8 mg orally, once daily after morning meal
Intervention Type
Drug
Intervention Name(s)
Silodosin
Intervention Description
Silodosin 4 mg orally, twice daily after morning and evening meal
Primary Outcome Measure Information:
Title
I-PSS
Description
Change in I-PSS total score from baseline
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
I-PSS, Qmax, QoL, ICS Male Questionnaire, goal achievement, Treatment satisfaction question
Description
The rate of patients who experience a decrease in I-PSS total score of 25% or higher The rate of patients who experience an improvement of at least 4 in I-PSS total score I-PSS Change in Qmax from baseline The rate of patients who experience an improvement of 30% or over in Qmax Change in the I-PSS voiding and storage scores from baseline Change in QoL score from baseline Change in ICS Male Questionnaire from baseline Patient's goal achievement score Treatment Satisfaction Question
Time Frame
12 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients who have been diagnosed with BPH through digital rectal exam or ultrasonographic findings and meet the following criteria. Outpatients aged 50 or over Patients with a total I-PSS score of 8 or higher and a QoL score of 3 or higher Patients with a prostate volume measured by transabdominal ultrasonography, or TRUS of 20 ml or greater Patients with a maximum urinary flow rate (Qmax_) of 15ml/sec or below (whose a void urinary volume of 120ml or greater) Exclusion Criteria: Patients with a residual urinary volume of 200ml or greater Patients with a history of prostatectomy Patients with a history of intrapelvic radiation therapy Patients with a history of prostatic hyperthermia Patients with prostate cancer or suspected prostate cancer Patients with complications considered likely to affect urinary passing such as neurogenic bladder, bladder calculus and active urinary tract infection. UTI Patients conducting self-catheterization Patients with renal impairment (serum creatinine of 3.0 mg/dl or greater) Patients with severe heptic disorders (hepatic insufficiency, cirrhosis, jaundice, hepatoma) or with a total bilirubin of 3.0mg/dL or greater or AST/ALT 2.5 times higher than normal level Patients with history of severe arrhythmia, cardiac failure, cardiac infarction, unstable angina, cerebral infarction within 6 months Patients with a history of an allergy to α-blockers Patients with orthostatic hypotension at around screening visit Patients with an experience of other investigational product treatments within 4 weeks form screening visit. Patients with a PSA of 10 or over, Patients with tumor identified by a prostate biopsy with a PSA of 4 or over (For patients taking 5α-reductase inhibitors for more than 3 months are presumed to have double than their actual PSA levels.) Patients who have taken unstable doses of antidepressants within the 3 months or who are expected to take unstable doses during the study Patients who have taken alpha blockers within the 2 weeks from the start of the therapy Patients who have taken unstable doses of 5α-reductase inhibitors within the 3 months from the start of the therapy or who are expected to take unstable doses during the study. Patients disqualified by the investigator.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jae Seung Paick, ph.D
Organizational Affiliation
Department of Urology, Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Catholic Univ., Bucheon ST.Mary's Hospital
City
Bucheon
Country
Korea, Republic of
Facility Name
Busan National Univ. Hospital
City
Busan
Country
Korea, Republic of
Facility Name
Konkuk Univ, Chungju Hospital
City
Chungju
Country
Korea, Republic of
Facility Name
Choongnam National Univ. Hospital
City
Daejeon
Country
Korea, Republic of
Facility Name
Eulji Univ. Hospital
City
Daejeon
Country
Korea, Republic of
Facility Name
Chonnam Univ. Hospital
City
Hwasun
Country
Korea, Republic of
Facility Name
Inha Univ. Hosipital
City
Incheon
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Chungang Univ. Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Korea Univ. Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Severance Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
The Catholic Univ., Seoul ST.Mary's Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Safety and Efficacy of QD Versus BID Silodosin With Lower Urinary Tract Symptoms Suggestive of BPH

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